MAUDE Adverse Event Report: OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Surgical procedure (2357)

Event Date 09/23/2008

Event Type  Injury  

Event Description

It was reported by the sales rep that during a gastric band procedure, on explant of the gastric band for erosion the collar was not connected.The band was explanted.Device was discarded.

Manufacturer Narrative

(b)(4): information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.Additional information requested: what date was the band implanted? originally implanted in 2008.Was an endoscopy done? upper endoscopy revealed the erosion.Was the band in the gastric lumen? at explant, the band had eroded into the gastric lumen and an intraoperative endoscopy revealed a gastrostomy which was repaired.Has the patient had any port infections? the patient had experienced no port infections if yes, when was it diagnosed and how many times were they treated for the infection? na what is the current status of the patient? believes the patient is currently doing well.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4255024
• MDR Text Key: 5017597
• Report Number: 3005992282-2014-00063
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1